4 Takeaways From The World Biosimilar Congress
4 Takeaways From The World Biosimilar Congress

Throughout this whirlwind two-day event, the panelists addressed the challenges of patient education and uptake, the pharmacovigilance of biosimilars, and how to navigate varying regulatory requirements in the global market. But there were four key messages relayed throughout this conference that are worth noting.

  • Tips For Identifying And Correcting Data Integrity Deficiencies In Your Organization
    Tips For Identifying And Correcting Data Integrity Deficiencies In Your Organization

    Often, the thought of addressing computer system issues and data integrity evaluations becomes overwhelming to quality personnel, and thus these responsibilities are deferred to members of the IT department. I intend to simplify this topic and share some straightforward actions that firms can take to identify and correct deficiencies.

  • “Growing” Biosimilars: How Plants Bolster Manufacturing Efficiency
    “Growing” Biosimilars: How Plants Bolster Manufacturing Efficiency

    Roughly 15 to 20 years ago, a number of pharmaceutical companies raised money to employ tobacco technology in drug development. Unfortunately, this rush did not lead to the success many were hoping for. However, the successes of recent players in this space suggest pharma could be entering a new age in plant-based manufacturing.

  • 6 Factors Driving Global Biosimilar Market Growth
    6 Factors Driving Global Biosimilar Market Growth

    There are a number of high-profile legal and regulatory decisions poised to shape the biosimilar market in the years to come. But there are also a few important trends developing that could give biosimilar makers the upperhand.

  • How Cuozzo v. Lee Could Impact The Biosimilar Market
    How Cuozzo v. Lee Could Impact The Biosimilar Market

    Kyle Bass' use of the Inter Partes Review (IPR) process stole headlines and greatly frustrated pharma players. However, a new case that could reshape the use of IPR currently has pharma innovators and generics/biosimilar makers on edge.

     

  • Will Medicare Part D Make Biosimilar Manufacturers Pay?
    Will Medicare Part D Make Biosimilar Manufacturers Pay?

    Despite biosimilars’ reputation as cheaper alternatives to costly biologics, Medicare Part D patients likely won’t see great savings at least not right away. According to a recent Avelare Health report, there are two ways patients could see reduced biosimilar out-of-pocket costs. But one of these solutions could place a big burden on biosimilar manufacturers. 

  • Applying Human Performance Models In FDA-Regulated Environments
    Applying Human Performance Models In FDA-Regulated Environments

    This article will provide regulatory context, address confidentiality concerns, and walk through an application based on an actual FDA 483.

  • What Is The Biosimilars Forum?
    What Is The Biosimilars Forum?

    The biosimilar industry is slowly growing in the U.S, and biosimilar manufacturers have joined forces to create The Biosimilars Forum. What are the goals of The Biosimilars Forum, and what impact has this organization had on this burgeoning market so far?

  • 7 Surprising Ways U.S. Physicians Are Approaching Biosimilars
    7 Surprising Ways U.S. Physicians Are Approaching Biosimilars

    Are physicians beginning to understand the value of biosimilars? According to a recent survey, there are seven key takeaways about physicians’ perceptions of biosimilars.

  • Are Emerging U.S. Biosimilar Policies At Risk Of Alienating Physicians?
    Are Emerging U.S. Biosimilar Policies At Risk Of Alienating Physicians?

    Educating physicians is a prime goal in the U.S. in order to ensure biosimilars are prescribed. However, are the U.S.'s emerging biosimilar policies already at risk of alienating physicians?

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BIOSIMILAR INSIGHTS

  • Biosimilars Event Chairperson Not What I Expected

    Although I’ve rarely traveled to shows since we launched Life Science Leader in 2009, I’m not unfamiliar with fulfilling this duty as an editor; I did it for six years prior to focusing exclusively on LSL. Still, there was one element of World Biosimilar Congress that seemed foreign to me — the role of the chairperson Richard DiCicco.

  • Choosing The Right Rapid Prototype Source For Device Development

    Successful prototyping begins with mechanical design that will operate properly when assembled and will be scalable for volume manufacturing. A working prototype can be a smooth progression if you employ the right resources and processes.

  • Executing Trials For Proposed Biosimilars: Challenges And Best Practices

    In this paper, we discuss how executing Phase III trials for biosimilars differs from that of New Chemical Entities (NCEs). Sponsors should understand from the outset that they will need to build in additional planning time and adopt tailored strategies for assessing feasibility, selecting sites, recruiting patients, procuring the comparator product, and ensuring the integrity of the study blind.

  • Strategies For Biosimilars Development

    The U.S. biopharmaceutical market recently experienced a watershed moment: a 21-3 Advisory Committee vote in February 2016 to approve the first monoclonal antibody biosimilar. CT-P13, Celltrion’s biosimilar to Remicade® (infliximab), targets autoimmune diseases, including Crohn’s disease, ulcerative colitis and rheumatoid arthritis.

  • 3 Regulatory Guidelines For Navigating China’s Drug Delivery And Medical Device Markets

    Global spending on healthcare medicines is expected to reach $1.3 trillion by end of year 2018. While many of these medicines may be developed in the traditional dosage forms, companies are increasingly developing more and more drug delivery devices, in order to deliver patient convenience, more effective routes of administration through targeted therapies, and value to the global payors. As the world’s second largest medical device market, China offers a significant opportunity for drug delivery companies to expand their global footprint in Asia.

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